[Federal Register Volume 61, Number 135 (Friday, July 12, 1996)]
[Proposed Rules]
[Pages 36688-36691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17660]


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[[Page 36689]]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[PP 6E4645/P672; FRL-5384-1]


Glyphosate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to establish a time-limited tolerance 
for residues of the herbicide glyphosate [N-(phosphonomethyl)glycine] 
in or on the raw agricultural commodity (RAC) oats at 20 parts per 
million (ppm). Because additional time is needed for the petitioner to 
submit additional details on the processing study and the composition 
of the foreign product, the Agency is proposing to grant this tolerance 
with a 3-year expiration date. This tolerance is being established to 
allow for the legal import of oats treated with glyphosate. Monsanto 
Company requested this tolerance in a petition submitted to EPA 
pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: Comments, identified by the docket control number [PP 6E4645/
P672], must be received on or before August 12, 1996.

ADDRESSES: By mail, submit written comments to: Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202. Comments and data may 
also be submitted to OPP electronically by sending electronic mail (e-
mail) to: [email protected]. Electronic comments must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Comments and data will also be accepted on 
disks in WordPerfect in 5.1 file format or ASCII file format. All 
comments and data in electronic form must be identified by the docket 
number [PP 6E4645/P672]. Electronic comments on this proposed rule may 
be filed online at many Federal Depository Libraries. Additional 
information on electronic submission can be found in the 
``SUPPLEMENTARY INFORMATION'' section of this document.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all that information as 
``Confidential Business Information'' (CBI). Information so marked will 
not be disclosed except in accordance with procedures set forth in 40 
CFR part 2. A copy of the comment that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 1132 at 
the Virginia address given above, from 8 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail, Robert J. Taylor, Product 
Manager, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: Rm. 241, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703)-305-6027; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Monsanto Company, 700 14th St., NW., Suite 
1100, Washington, DC 20005, has submitted a pesticide petition (PP) 
6E4645 proposing to amend 40 CFR 180.364, pursuant to section 408(d) of 
the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. 346(a), by 
establishing a regulation to permit residues of the herbicide 
glyphosate [N-(phosphonomethyl)glycine] resulting from the application 
of the isopropylamine salt and/or the monoammonium salt of glyphosate 
in or on the raw agricultural commodity (RAC) oats at 20.0 parts per 
million (ppm). The data submitted in the petitions and other relevant 
material have been evaluated. The glyphosate toxicological data listed 
below were considered in support of these tolerances.
    1. Several acute toxicology studies placing technical-grade 
glyphosate in Toxicity Category III and Toxicity Category IV.
    2. A 1-year feeding study with dogs fed dosage levels of 0, 20, 
100, and 500 milligrams/kilogram/day (mg/kg/day) with a no-observable-
effect level (NOEL) of 500 mg/kg/day.
    3. A 2-year carcinogenicity study in mice fed dosage levels of 0, 
150, 750, and 4,500 mg/kg/day with no carcinogenic effect at the 
highest dose tested (HDT) of 4,500 mg/kg/day.
    4. A chronic feeding/carcinogenicity study in male and female rats 
fed dosage levels of 0, 3, 10, and 31 mg/kg/day (males) and 0, 3, 11, 
or 34 mg/kg/day (females) with no carcinogenic effects observed under 
the conditions of the study at dose levels up to and including 31 mg/
kg/day (HDT) (males) and 34 mg/kg/day (HDT) (females) and a systemic 
NOEL of 31 mg/kg/day (HDT) (males) and 34 mg/kg/day (HDT) (females). 
Because a maximum tolerated dose (MTD) was not reached, this study was 
classified as supplemental for carcinogenicity.
    5. A chronic feeding/carcinogenicity study in male and female rats 
fed dosage levels of 0, 89, 362, and 940 mg/kg/day (males) and 1, 113, 
457, and 1,183 mg/kg/day (females) with no carcinogenic effects noted 
under the conditions of the study at dose levels up to and including 
940/1,183 mg/kg/day (males/females) (HDT) and a systemic NOEL of 362 
mg/kg/day (males) based on an increased incidence of cataracts and lens 
abnormalities, decreased urinary pH, increased liver weight and 
increased liver weight/brain ratio (relative liver weight) at 940 mg/
kg/day (males) (HDT) and 457 mg/kg/day (females) based on decreased 
body weight gain at 1,183 mg/kg/day (females) (HDT).
    6. A developmental toxicity study in rats given doses of 0, 300, 
1,000, and 3,500 mg/kg/day with a developmental NOEL of 1,000 mg/kg/day 
based on an increase in number of litters and fetuses with unossified 
sternebrae, and decrease in fetal body weight at 3,500 mg/kg/day, and a 
maternal NOEL of 1,000 mg/kg/day based on decrease in body weight gain, 
diarrhea, soft stools, breathing rattles, inactivity, red matter in the 
region of nose, mouth, forelimbs, or dorsal head, and deaths at 3,500 
mg/kg/day (HDT).
    7. A developmental toxicity study in rabbits given doses of 0, 75, 
175, and 350 mg/kg/day with a developmental NOEL of 350 mg/kg/day 
(HDT); a maternal NOEL of 175 mg/kg/day based on increased incidence of 
soft stool, diarrhea, nasal discharge, and deaths at 350 mg/kg/day 
(HDT).
    8. A multigeneration reproduction study with rats fed dosage levels 
of 0, 3, 10, and 30 mg/kg/day with a developmental NOEL of 10 mg/kg/day 
based on an apparent increased incidence of focal tubular dilation of 
the kidney (both unilateral and bilateral combined) of male F3b pups.
    9. A two generation reproduction study with rats fed dosage levels 
of 0, 100, 500, and 1,500 mg/kg/day with a developmental NOEL of 500 
mg/kg/day based on decreased pup body weight and body weight gain on 
lactation days 14 and 21 at 1,500 mg/kg/day (HDT), a systemic NOEL of 
500 mg/kg/day based on soft stools in Fo and F1 males and females at 
1,500 mg/kg/day (HDT) and a reproductive NOEL of 1,500 mg/kg/day (HDT). 
Additionally, since there was no increase in focal tubular dilation

[[Page 36690]]

of the kidney of the pups at any dose level, the findings at 30 mg/kg/
day in the earlier study was considered sparious.
    10. Mutagenicity data included chromosomal aberration in vitro (no 
aberrations in Chinese hamster ovary cells were caused with and without 
S9 activation); DNA repair in rat hepatocyte; in vivo bone marrow 
cytogenic test in rats; rec-assay with B. subtilis; reverse mutation 
test with S. typhimurium; Ames test with S. typhimurium; and dominant-
lethal mutagenicity test in mice (all negative).
    The reference dose (RfD) based on a developmental study with 
rabbits (NOEL of 175 mg/kg/ bwt/day) and using a hundred-fold safety 
factor is calculated to be 2.0 mg/kg body weight/day. The theoretical 
maximum residue contribution (TMRC) for published tolerances is 
0.021460 mg/kg bwt/day or 1.0% of the RfD for the overall U.S. 
population. This current action on oats will contribute 0.001644 mg/kg/
day to the TMRC. This tolerance will utilize a total of 0.082% of the 
RfD for the overall U.S. population. For U.S. subgroup population, 
nonnursing infants, the current action and previously established 
tolerances utilize, a total of 3.2% of the RFD, assuming that residue 
levels are at the established tolerance levels and that 100% of the 
crop is treated.
    Data desirable for this petition include additional details for the 
processing study and composition of the foreign product. The Agency is 
granting the tolerance for oats with a 3-year expiration date to allow 
the petitoner, Monsanto Company, to provide the required data.
    There are currently no actions pending against the continued 
registration of this pesticide. No detectable residues of N-
nitrosoglyphosate, a contaminant of glyphosate, are expected to be 
present in the commodities for which tolerances are established. The 
carcinogenic potential of glyphosate was first considered by a panel, 
then called the Toxicology Branch AD Hoc Committee, in 1985. The 
Committee, in a consensus review dated March 4, 1985, classified 
glyphosate as a Group C carcinogen based on an increased incidence of 
renal tumors in male mice. The Committee also concluded that dose 
levels tested in the 26-month rat study were not adequate for 
assessment of glyphosate's carcinogenic potential in this species. 
These findings, along with additional information, including a 
reexamination of the kidney slides from the long-term mouse study, were 
referred to the FIFRA Scientific Advisory Panel (SAP). In its report 
dated February 24, 1986, SAP classified glyphosate as a Group D 
Carcinogen (inadequate animal evidence of carcinogenic potential). SAP 
concluded that, after adjusting for the greater survival in the high-
dose mice compared to concurrent controls, that no statistically 
significant pairwise differences existed, although the trend was 
significant.
    The SAP determined that the carcinogenic potential of glyphosate 
could not be determined from existing data and proposed that the rat 
and/or mouse studies be repeated in order to classify these equivocal 
findings. On reexamination of all information, the Agency classified 
glyphosate as a Group D carcinogen and requested that the rat study be 
repeated and that a decision on the need for a repeat mouse study would 
be made upon completion of review of the rat study.
    Upon receipt and review of the second rat chronic feeding/
carcinogenicity study, all toxicological findings for glyphosate were 
referred to the Health Effects Division Carcinogenicity Peer Review 
Committee on June 26, 1991, for discussion and evaluation of the weight 
of evidence on glyphosate with particular emphasis on its carcinogenic 
potential. The Peer Review Committee classified glyphosate as a Group E 
(evidence of noncarcinogenicity for humans), based upon lack of 
convincing carcinogenicity evidence in adequate studies in two animal 
species. This classification is based on the following findings: (1) 
None of the types of tumors observed in the studies (pancreatic islet 
cell adenomas in male rat, thyroid c-cell adenomas and/or carcinomas in 
male and female rats, hepatocellular adenomas and carcinomas in male 
rats, and renal tubular neoplasms in male mice) were determined to be 
compound related; (2) glyphosate was tested up to the limit dose on the 
rat and up to levels higher than the limit dose in mice; and (3) there 
is no evidence of genotoxicity for glyphosate. Accordingly, EPA 
concludes that glyphosate has not been ``found to induce cancer when 
ingested by man or animal.'' 21 U.S.C. 348(c)(3).
    The nature of the residue in plants is adequately understood. The 
residue to be regulated is the parent glyphosate. Adequate methodology 
(HPLC) with flurometric detection is available for enforcement 
purposes, and the methodology has been published in the Pesticide 
Analytical Manual (PAM), Vol. II. The submitted residue data adequately 
support the proposed tolerance of 20 ppm. Any secondary residues 
occurring in milk, eggs, meat, fat, liver, and kidney of cattle, goats, 
horses, hogs, and sheep be covered by existing tolerances.
    Based on the information cited above, the Agency has determined 
that when used in accordance with good agricultural practice, this 
ingredient is useful and the tolerance established by amending 40 CFR 
part 180 will protect the public health. It is proposed, therefore, 
that the tolerance be established as set forth below.
    Any person who has registered or submitted and application for 
registration of a pesticide under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA) as amended, which contains any of the 
ingredients listed herein, may request within 30 days after publication 
of this document in the Federal Register that this proposal be referred 
to an Advisory Committee in accordance with Section 408 of the Federal 
Food, Drug, and Cosmetic Act.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [6E4645/P672]. All written comments filed in 
response to this petition will be available in the Public Response and 
Program Resources Branch, at the address given above from 8 a.m. to 
4:30 p.m., Monday through Friday, except legal holidays.
    A record has been established for this rulemaking under docket 
number [PP 6E4645/P672] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The public record is located in Rm. 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    [email protected]
    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any comments electronically into printed, paper form 
as they are received and will place the paper copies in the rulemaking 
record which will

[[Page 36691]]

also include all comments submitted directly in writing. The official 
record is the paper record maintained at the address in ``ADDRESSES'' 
at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
the order defines a ``significant regulatory action'' as an action that 
is likely to result in a rule (1) Having an annual effect on the 
economy of $100 million or more, or adversely and materially affecting 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities (also referred to as ``economically 
significant''); (2) creating serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement, grants, user 
fees, or loan programs or the rights and obligation of recipients 
thereof; or (4) raising novel legal or policy issues arising out of 
legal mandates, the President`s priorities, or the principles set forth 
in this Executive Order. Pursuant to the terms of this Executive Order, 
EPA has determined that this proposed rule is not ``significant'' and 
is therefore not subject to OMB review.
    This action does not impose any enforceable duty, or contain any 
``unfunded mandates'' as described in Title II of the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
specified by Executive Order 12875 (58 FR 58093, October 28, 1993), 
entitled ``Enhancing the Intergovernmental Partnership,'' or special 
consideration as required by Executive Order 12898 (59 FR 7629, 
February 29, 1994).
    Pursuant to the requirements of the Regulatory Flexibility Act 
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 
has determined that regulations establishing new tolerances or raising 
tolerance levels or establishing exemptions from tolerance requirements 
do not have a significant impact on a substantial number of small 
entities. A certification statement to this effect was published in the 
Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests.

    Dated: June 28, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, it is proposed that part 180 be amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.364 is amended by revising the entry for grain crops 
(except wheat) under paragraph (a) in the table therein and adding a 
new paragraph (e) to read as follows:


Sec. 180.364   Glyphosate: tolerances for residues.

    (a)  *    *    *

                                                                        
------------------------------------------------------------------------
                 Commodity                        Parts per million     
------------------------------------------------------------------------
                                                                        
                        *    *    *    *    *                           
grain crops (except wheat and oats).......  0.13                        
                                                                        
                        *    *    *    *    *                           
------------------------------------------------------------------------

    *      *      *      *      *
    (e) A tolerance to expire (Insert date 3-years after date of 
publication of the final rule in the Federal Register) is established 
for residues of the herbicide glyphosate (N-(phosphonomethyl)glycine) 
resulting from the application of the isopropylamine salt of glyphosate 
and/or the monoammonium salt of glyphosate in or on the raw 
agricultural commodity oat at 20 parts per million.

[FR Doc. 96-17660 Filed 7-11-96; 8:45 am]
BILLING CODE 6560-50-F